How is a Category II drug classified?

A Category II drug is specifically classified as an over-the-counter medication that is not generally recognized as safe or effective for the claimed therapeutic indication. This classification reflects the understanding that while the drug may be available without a prescription, it has not met the required standards for safety and efficacy as mandated by regulatory bodies like the FDA.

This classification is important because it informs both healthcare providers and consumers about the limitations associated with the use of such medications. The distinction emphasizes that, despite being available over the counter, these drugs may not provide the promised benefits and could potentially pose risks to users.

In contrast, the other options address different categories or characteristics of drugs. For example, a drug that is always safe and effective does not fit into the Category II classification, which inherently recognizes a lack of universal safety and effectiveness. Similarly, prescription-only drugs denote a separate classification based on the necessity for medical supervision, and a drug with high abuse potential reflects a different concern related to substance control and misuse rather than safety and efficacy. Therefore, understanding the specific definition of Category II is crucial for both proper medication use and patient safety.